BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8089407 · Received November 20, 2018

    Report

    Report Number
    3010606081-2018-00019
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 20, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS. USER REPORTS SHE HAS RECEIVED READINGS IN THE 300 MG/DL RANGE FOR A FEW DAYS AND AS A RESULT WENT TO THE EMERGENCY ROOM. AT THE HOSPITAL HER BLOOD GLUCOSE WAS 125 MG/DL. IN THE INITIAL INVESTIGATION IT WAS FOUND THAT USER USED EXPIRED STRIPS (STRIPS EXPIRED ON AUGUST 29, 2018, LOT # 16Y16A1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929232 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-04 1805021

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization